FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

July 2, 1997 97-27

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Chocolate Marshmallow Easter Eggs (Milk & Dark), 3/4
ounces, individually wrapped in cellophane. Recall
#F-478/479-7.
CODE Lot numbers: 7013,7022, 7024, 7027, 7045.
MANUFACTURER Gertrude Hawk Chocolates, Inc., Dunmore,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on April 9, 1997.
followed by press release on April 10, 1997, and
letter dated April 14, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Firm estimates little if any product remains on market.
REASON The products' labels do not declare egg white
(albumen).

_______________
PRODUCT Gravy mixes and beef stock base:
a) French's Herb Brown Gravy Mix, packaged in .75 ounce
foil-lined envelopes
b) Durkee Herb Brown Gravy Mix, packaged in .75 ounce foil
lined envelopes
c) Spice Islands Gourmet Blend Beef Stock Base, packaged in
3.2 ounce bottles.
Recall #F-483/485-7.
CODE All lots.
MANUFACTURER Burns Philp Foods, Inc., Ankeny, Iowa.
RECALLED BY Manufacturer, by press release on March 27, 1997,
followed by telephone and fax on March 28, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 39,295 12-envelope cases; b) 17,854 12-envelop
cases; c) 9,103 cases containing 8
6-packs were distributed.
REASON Product contains undeclared hydrolyzed peanut protein.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Clindamycin Phosphate Injection in 2 ml, 4 ml, 6 ml
single dose vials and 60 ml and 100 ml bulk pharmacy
packages. Recall #D-183-7.
CODE SIZE (mL) RECALLED LOT # EXP. DATE
2a P6E007 11/97
4a P6E014 11/97
6a P6E007F1 11/97
60b P6E305* 11/97 lot mfg.
for private label
Solopak Labs
60b P6K318 02/98
100b P6E313 11/97
100b P6K320 02/98
a = Single dose vials
b = Pharmacy bulk package.
MANUFACTURER Gensia Laboratories, Irvine, California.
RECALLED BY Manufacturer, by fax on March 13, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 104,459 units were distributed. Firm estimated that
50% of product remained on market at time of recall
initiation.
REASON Bulk Clindamycin was recalled by Roussel Corporation
(parent firm of Biochimica Opos) due to AADA
(Abbreviated Antibiotic Drug Application) discrepancies
regarding manufacturing process.

_______________
PRODUCT Oxygen USP, Compressed Medical Gas, Rx, held in various
high pressure cylinders.
Recall #D-211-7.
CODE Lot #WSE017.
MANUFACTURER The Welders Supply Company, Childress, Texas.
RECALLED BY Manufacturer, by letter on or about May 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY Undetermined.
-2-REASON Failure to maintain records required under current good
manufacturing practice regulations.

_______________
PRODUCT Oxygen, USP, Rx compressed medical gas, held in T, K,
S, AND, and ANE high pressure cylinders. Recall
#D-212-7.
CODE Lot numbers: E42-7024, E42-7044, E42-7066, E42-7083,
E42-7091, E42-7092, E42-7099.
MANUFACTURER C.S. Gases, Inc., Buffalo, New York.
RECALLED BY Manufacturer, by telephone on May 16, 1997,
followed by letter on May 19, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY Approximately 127 cylinders were distributed.
REASON Failure to properly calibrate finished product testing
equipment.

_______________
PRODUCT Schein Pharmaceutical Procainamide Hydrochloride
Extended-Release Tablets, USP 500 mg, in bottles of
100, indicated for the treatment of documented
arrhythmias.
Recall #D-213-7.
CODE Lot #D6A0204 EXP 2/98.
MANUFACTURER Danbury Pharmacal, Danbury, Connecticut.
RECALLED BY Danbury Pharmacal, Inc., Caramel, New York, by
letter on May 14, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION California, Connecticut, Illinois, Florida,
Georgia, Kentucky, Massachusetts, Missouri, New
Jersey, New York, Ohio, Tennessee, Texas.
QUANTITY 1,939 bottles were distributed.
REASON Dissolution failure (stability).

_______________
PRODUCT Apothecary Products OTC drug pouches in convenience
packs:
a) Maximum Strength Tylenol Sinus Convenience Packs, 2
caplets, 500 mg Acetaminophen/30 mg Pseudoephedrine HCl; b)
Maximum Strength Aspirin Free Anacin Convenience Packs, 2
tablets, 500 mg/Acetaminophen.
Recall #D-219/220-7.
CODE Lot numbers: a) 4S2296B; b) NL405.
MANUFACTURER Apothecary Products, Inc., Burnsville, Minnesota
(repacker of the OTC drug pouches in the
convenience packs and manufacturer of the 15 prong
displays. The OTC drugs for the displays are
manufactured by various OTC drug manufacturers).

-3-RECALLED BY Apothecary Products, Inc., Burnsville, Minnesota,
by telephone beginning on May 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 17 of the 15-prong convenience display racks were
distributed with 90 convenience packs of OTC drugs (6
convenience packs of each of 15 different OTC drugs).
REASON Mis-packaged. The convenience packs are held on a 15
prong display as a labeled card holding a labeled pouch
of one adult drug dosage. The cards are incorrectly
labeled however, the pouches each holding the products
are correctly labeled with the actual product each
contains. The convenience packs labeled as containing
Maximum Strength Tylenol Sinus actually contain Sudafed
30 mg Pseudoephedrine Hydrochloride Tablets (2). The
pouch holding the product is correctly labeled as
Sudafed. The convenience packs labeled as containing
Maximum Strength Aspirin Free Anacin actually contain
Bayer Aspirin Tablets (2), 325 mg per tablet. The
pouch holding the product is correctly labeled as Bayer
Aspirin.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Guiatuss AC, in 1 gallon, 16 ounce, 8 ounce and 4 ounce
bottles, an expectorant cough suppressant. Recall
#D-214-7.
CODE Lot numbers: QN6718, QN6719, QS6885, QB7075.
MANUFACTURER Alpharma, U.S. Pharmaceutical Division, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated April 25, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 286,944 units were distributed.
REASON Presence of precipitate.

_______________
PRODUCT Enplus HD Syrup (Hydrocodone Bitartrate 2.5
mg/Phenylephrine HCl 5 mg/Chlorpheniramine Maleate 2
mg), in pint bottles, used for the relief of cough and
congestion. Product is also manufactured under the
names of Efasin-HD Plus Liquid and Echotuss-HC Syrup.
Recall #D-215-7.
CODE Lot numbers: 60702 and 70108.
MANUFACTURER Elgee, Inc., Rosenberg, Texas.
RECALLED BY Manufacturer, by telephone, followed by letter on
June 9, 1997. Firm-initiated recall ongoing.
-4-DISTRIBUTION Georgia, Ohio, Michigan.
QUANTITY 5,010 pints of lot 60701 and 6,912 pints of lot 70108
were distributed. Firm estimated that none of lot
60701 and 558 pints of lot 70108 remained on market at
time of recall initiation.
REASON Presence of particulate matter.

_______________
PRODUCT Bumetanide Injection, USP, 0.25 mg/ml, Rx injectable
diuretic. Recall #D-216-7.
CODE Lot #LB224 EXP 2/99.
MANUFACTURER Ben Venue Laboratories, doing business as Bedford
Laboratories, Bedford, Ohio.
RECALLED BY Manufacturer, by letter dated June 4, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 21,720 vials were distributed.
REASON Discoloration.

_______________
PRODUCT Loxitane (Loxapine Succinate) 10 mg Capsules, Rx
antidepressant, in unit dose 10 (2x5) strips and
bottles of 1,000, under the Lederle Laboratories label.
Recall D-218-7.
CODE Lot numbers: 445-787 and 445-788.
MANUFACTURER Wyeth-Ayerst/Lederle, Pearl River, New York.
RECALLED BY Wyeth-Ayerst Laboratories, Frazer, Pennsylvania,
by letter on June 11, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Oklahoma, Colorado, Texas, Tennessee, North
Carolina.
QUANTITY 4 boxes containing 100 blister packed capsules and 11
bottles of 1000 were distributed.
REASON Superpotency.

_______________
UPDATE Alpharma, (Barre-National) Baltimore, MD, (OTC)
Guiatuss DAC, Syrup, cough
suppressant/expectorant/nasal decongestant
(Guiafenesin, Pseudoephedrine Hydrochloride/Codeine
Phosphate),
Recall #D-093-7 which appeared in the February 12, 1997,
Enforcement Report has been extended to include the
following lot numbers: RD6224, RH6363, RH6401, RJ6424,
RL6629.

-5-_______________
UPDATE Alpharma, (Barre-National) Baltimore, MD, Guiatuss AC
Syrup, sugar-free cough suppressant/expectorant
(Guiafenesin, Codeine Phosphate, Recall #D-120-7 which
appeared in the March 5, 1997, Enforcement Report has
been extended to include the following lot numbers:
RH6361, RH6360, RF6312, RF6272, RF6311, RC6126, RC6125,
RC6179, RD6223, RC6178.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-922-7.
CODE Unit #18GH13741.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated February 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
that was reported as clotted.

_______________
PRODUCT Platelets. Recall #B-923-7.
CODE Unit #18E94092.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated April 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
that was reported as clotted.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-929/931-7.
CODE Unit #42FH55458.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated February 27, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who received
a human bite within 12 months of donation.

-6-_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitated
AHF; d) Recovered Plasma. Recall #B-932/935-7.
CODE Unit numbers: a) 11039-4109, 11042-6008, 11040-6119,
11038-3835, 11036-6315; b) 11042-6008, 11039-4109; c) 11040-6119,
11038-3835, 11036-6315; d) 11040-6119, 11038-3835,
11036-6315, 11042-6008, 11039-4109.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters between March 11, 1997 and April 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas, New Mexico, Arizona, Virginia, North
Carolina, Switzerland.
QUANTITY a) 5 units; b) 2 units; c) 3 units; d) 5 units were
distributed.
REASON Blood products tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested
repeatedly reactive for anti-HIV-1, Western blot
negative.

_______________
PRODUCT Platelets. Recall #B-936-7.
CODE Unit #18FR05432.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by telephone and letter on April 3,
1997. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
that was reported as clotted.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-937/939-7.
CODE Unit #18FE36259.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated January 21 and 30,
1997, or February 17, 1997. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was
taking the drug Zovirax.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-940/941-7.
-7-CODE Unit numbers: 13FH30493, 13Q89198, 13FM07535.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated March 5, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-952/953-7.
CODE Unit #24193-9501.
MANUFACTURER United Blood Services, Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated September 30, 1996. Firm-initiated
recall complete.
DISTRIBUTION South Dakota and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported
a history of hepatitis A.

_______________
PRODUCT Red Blood Cells. Recall #B-955-7.
CODE Unit numbers: 32LF08172 and 32LL19460.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated September 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Blood products tested CMV positive were labeled as CMV
negative.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-956/957-7.
CODE Unit numbers: a) 32KH22668; b) 32KG26795, 32KG27375.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated September 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY a) 1 unit; b) 2 units were distributed.
REASON Blood products tested positive for CMV were distributed
labeled as CMV negative.

-8-_______________
PRODUCT Red Blood Cells. Recall #B-959-7.
CODE Unit #32V42390.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on November 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that may have
compromised the sterility of the collection system.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-960/962-7.
CODE Unit #32K48364.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter and fax dated April 9,
1997, and by fax. Firm-initiated recall complete.
DISTRIBUTION Wisconsin and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), and had no repeat testing performed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-963-7.
CODE Unit numbers: 40P51744, 40P52080, 40P52203, 40P52257,
40P52323, 40P52351, 40P52466, 40P52636, 40P52659, 40P52666.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on March 28 and 31,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 10 units were distributed.
REASON Blood product tested negative for CMV, but were
collected from donors who previously tested CMV
positive.

_______________
PRODUCT a) Red Blood Cells, Irradiated; b) Platelets,
Irradiated. Recall #B-964/965-7.
CODE Unit numbers: a) 32KF15176, 32KH24605, 32KH24580; b)
32KP01929.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated August 28, 1996.
Firm-initiated recall complete.
-9-DISTRIBUTION Wisconsin.
QUANTITY a) 3 units; b) 1 unit was distributed.
REASON Blood products were inadequately irradiated due to a
malfunctioning irradiator.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-942-7.
CODE Unit #12421-6322.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 22, 1997. Firm-initiated
recall complete.
DISTRIBUTION New Mexico.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for greater
than 30 minutes.

_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF. Recall
#B-944/945-7.
CODE Unit #21GG69290.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated March 27, 1997, and
by telephone on March 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION Oregon and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were distributed after the donor
reported a post donation illness.

_______________
PRODUCT Recovered Plasma. Recall #B-946-7.
CODE Unit #2999898.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer, by fax on September 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after the donor reported
a post donation illness.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma.
Recall #B-947/951-7.

-10-CODE Unit numbers: a) 11032-2077, 11033-1274, 11028-8235,
11036-1060, 11034-5722, 11033-7251, 11038-6913, 11037-8114; b)
11036-1060, 11037-8114, 11034-5722; c) 11038-6913,
11032-2077; d) 11028-8235; e) 11033-7251, 11028-8235, 11036-1060,
11033-1274, 11037-8114, 11034-5722.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Manufacturer, by letters dated February 24, 1997,
and May 1, 1997. Firm-initiated recall complete.
DISTRIBUTION Texas, New Mexico, California, North Carolina,
Switzerland.
QUANTITY a) 8 units; b) 3 units; c) 2 units; d) 1 unit; e) 6
units were distributed.
REASON Blood products tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested
repeatedly reactive for anti-HIV-1, Western blot
negative.

_______________
PRODUCT Red Blood Cells. Recall #B-954-7.
CODE Unit #24194-7355, 21494-8716, 24194-8719, 24194-8830,
24194-8836.
MANUFACTURER United Blood Services, Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on November 13, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 5 units were distributed.
REASON Blood products were shipped at an unacceptable
temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-958-7.
CODE Unit #32KF12324.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on May 20, 1996.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration
date.

-11-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========
_______________
PRODUCT 5.0 mm TI Shaft Screws, used to compress or fixate
fractures of bones in the femoral neck so they can
heal:
(a) 5.0mm TI Shaft Screw, 70mm, Part #457.070;
(b) 5.0mm TI Shaft Screw, 75mm, Part# 457.075.
Recall #Z-667/668-7.
CODE Lot numbers: (a) A3CY415; (b) A3CY644.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by E-mail on
October 25, 1996. Firm-initiated recall complete.
DISTRIBUTION (a) Massachusetts, California, Florida, Illinois,
Pennsylvania, Switzerland; (b) Massachusetts,
Wisconsin, New York, Texas, Nebraska, California,
Florida, Illinois, pennsylvania, Switzerland.
QUANTITY (a) 37 screws; (b) 41 screws were distributed.
REASON The labels indicated that 70mm screw was 75mm shaft
screw and the 75 mm screw was a 70mm shaft screw.

_______________
PRODUCT Model No 2800 Portable Ventilator for delivery of gas
to patients dependent on artificial respiration.
Recall #Z-672-7.
CODE All units.
MANUFACTURER Nellcor Puritan Bennett, Carlsbad, California.
RECALLED BY Manufacturer, by letter dated August 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,500 units were distributed.
REASON The High Pressure Alarm does not sound if set a 57 or
60 cm. of water, and the Pressure Relief Valves may
stick in the closed position.

_______________
PRODUCT Industrial Laser Products, used for automotive chassis
alignment: (a) Model Homer; (b) Model ELVIS. Recall
#Z-676/677-7.
CODE None.
MANUFACTURER Romer, Inc., Carlsbad, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action plan on June 3, 1997. Firm-initiated field
correction ongoing.
DISTRIBUTION Michigan and Ohio.
QUANTITY (a) 3 units; (b) 2 units were distributed.

-12-REASON Laser products failed to comply with the Federal laser
product performance standard, 21 CFR 1010.2, 1010.3,
1040.10(f)(5), 1040.10(g)(2)(ii), 1040.10(g)(5), and
1040.10(h)(1) in that they lacked certification,
identification, emission indicators, warning logotype
and aperture labels and user information.

_______________
PRODUCT Sensicath Blood Gas Measurement System, a sterile,
single-use disposable device which is incorporated into
arterial lines for measurements up to 72 hours. Recall
#Z-678-7.
CODE All serial numbers.
MANUFACTURER Optical Sensors, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter dated May 5, 1997.
Firm-initiated recall complete.
DISTRIBUTION California, Connecticut, Georgia, Illinois,
Maryland, New Jersey, Ohio, Oklahoma, Texas,
Wisconsin.
QUANTITY 190 units were distributed.
REASON The device, at a period less than 144 hours, will
produce inaccurate pH measurements if the sensor is not
recalibrated.

_______________
PRODUCT A.T.S. reusable Cylindrical Tourniquet Cuffs, used to
exert enough pressure on the arterial blood flow within
a limb to produce a bloodless operating field: a) DPSB
ATS Cuffs; b) SPSB ATS Cuffs; c) DPDB ATS Cuffs; d)
SPDB ATS Cuffs. Recall #Z-679-682-7.
CODE a) DPSB ATS Cuffs:
Catalog No. Size(in): Lot No:
60-7500-001-00 8 91867200, 91825800
60-7500-002-00 12 91874800, 91840700,
91811900
60-7500-003-00 18 91880200, 91862800,
91843500, 91830000
60-7500-004-00 24 91859400, 91822900,
91836600, 91889900
60-7500-005-00 30 91894100, 91862900,
91836700
60-7500-006-00 34 91902800, 91900100,
91880300, 91859500,
91836800, 91823600
60-7500-007-00 42 91885500, 91863000,
91836900;

-13- b) SPSB ATS Cuffs:
60-7600-001-00 8 91900400, 91837100
60-7600-002-00 12 91885600, 91837200
60-7600-003-00 18 91900500, 91880400,
918455600
60-7600-004-00 24 91875000, 91840800
60-7600-005-00 30 91885700
60-7600-006-00 34 91885800, 91867300,
91840900, 91826100
60-7600-007-00 42 91885900, 91841000;
c) DPDB ATS Cuffs:
60-7555-001-00 12 91872000, 91825900
60-7555-002-00 18 91837000, 91874900,
91859600
60-7555-003-00 24 91872100, 91855500;
d) SPDB ATS Cuffs:
60-7666-002-00 18 91875100, 91841100
60-7666-003-00 24 91867400.
MANUFACTURER Zimmer Patient Care Division, Statesville, North
Carolina.
RECALLED BY Zimmer Patient Care Division, Dover, Ohio, by
letters on May 23 and 30, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 9,564 cuffs were distributed; firm estimated that 90%
remained on market at time of recall initiation.
REASON The cuff has the potential to deflate due to breakage
or cracking of the tourniquet port where it is welded
to the cuff bladder material.

_______________
PRODUCT Vision FX Series Nuclear Imaging System Patient Table.
Recall #Z-683-7.
CODE Serial numbers: 93-96, 100-173, P2, PP3.
MANUFACTURER SMV America, Twinsburg, Ohio.
RECALLED BY Manufacturer, by visit. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Puerto Rico, France, Guatemala.
QUANTITY 79 systems were distributed.
REASON The fasteners, used to assemble the motorized patient
table, were inappropriate for the proper functioning of
the device.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Percutaneous Reduction Forceps Module, Part #304.565,
used to measure the length of implantable screws.
Recall #Z-669-7.
CODE All lot numbers.
MANUFACTURER Synthes (USA), Monument, Colorado.
-14-RECALLED BY Synthes (USA), Paoli, Pennsylvania, by memorandum
on March 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Canada, Switzerland.
QUANTITY Firm estimates none remains on the market.
REASON The screw length gauge in the module was incorrectly
etched 18mm and 20mm instead of 20mm and 24mm.

_______________
PRODUCT Dade Paramax Cuvettes 10,000 with accessories: (a)
Catalog #B6115-503; (b) Catalog #B6115-503C. Recall
#Z-670/671-7.
CODE Lot No. 286; Spool Nos. 4286-0 13120 through 4286-0 13129;
4286-0 15351 through 4286-0 15360; and 4286-0 15381
through 4286-0 15390.
MANUFACTURER Dade International, Irvine, California.
RECALLED BY Manufacturer, by notice dated May 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON The cuvettes in some spools may have undersized optical
windows which may lead to erroneous results on
controls, calibrators, and patient samples.

SAFETY ALERT: ===============================================
_______________
PRODUCT Haemonetics PCS Plasma Collection System. Safety Alert
#N-015-7.
CODE Software versions prior to Rev. E.
MANUFACTURER Haemonetics Corporation, Braintree, Massachusetts.
ALERTED BY Manufacturer, by updating software on August 8,
1995, by fax on May 24, 1996, and by releasing
revised software on June 4, 1996. Corrective
action was completed in September 1996.
DISTRIBUTION Nationwide.
QUANTITY 1,776 instruments were distributed.
REASON Firm instituted a software upgrade (Revision E) to
alert operators if there is a greater than 4 gram
weight change in the collection bag between the end of
the collection cycle and the end of the saline
infusion, it could dilute the test sample which is used
for viral marker testing.

-15-

END OF ENFORCEMENT REPORT FOR JULY 2, 1997. BLANK PAGES MAY
FOLLOW.

####

End of Enforcement Report for